Merck Associate Principal Scientist, Statistical Programming - Study Data Tabulation Model (SDTM) in Rahway, New Jersey
Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.
Develop and validate global programming standards and tools for the production of Study Data Tabulation Model (SDTM) datasets.
Design and develop complex programming algorithms and user interfaces.
Supporting project teams in creating SDTM deliverables for Analysis and Reporting activities and submission.
Collaborating with project teams to prepare the Case Report Tabulation (CRT) submission deliverables including use of Pinnacle 21 Enterprise.
Education Minimum Requirements:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.
MS (preferred) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.
Required Experience and Skills:
Expertise in SAS for system development and clinical trial programming.
Broad knowledge in developing analysis and reporting deliverables for Research & Development (R&D) projects (data, analyses, tables, graphics, listings).
Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), Define.XML, SDRG, aCRF; knowledge of Analysis Dataset Model (ADaM) and Analysis Data Reviewer’s Guide (ADRG) considered a plus.
Excellent communication and interpersonal skills and ability to negotiate and partner effectively.
Excellent written, oral, and presentation skills.
Excels in technical writing, able to convert complex ideas and information into simple readable form.
Strong project management skills; Manage at a program level; influences approach/s and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.
Demonstrated success in the assurance of deliverable quality and process compliance.
Familiarity with statistics and clinical data management concepts.
Preferred Experience and Skills:
Strong working knowledge of reporting processes Standard Operating Procedures (SOPs) and software development life-cycle (SDLC).
Provide technical and/or programming guidance and mentoring to colleagues.
Deals well with change and seamlessly assimilates to new projects and stakeholders.
Ability to anticipate stakeholder requirements.
Strategic thinking ability to turn strategy into tactical activities.
Ability and interest to work across cultures and geographies.
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.
Develop and manage project plan using Microsoft Project or similar package.
Active in industry forums and professional societies.
Process improvement and familiarity with Meta Data Repositories.
United States and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of CRT SDTM study data standard deliverables.
Strong knowledge of study data standards.
Up-versioning activities to specific versions of Statistical Analysis System (SDTM).
Participation in industry teams and conferences on best practices.
Membership on departmental strategic initiative project teams.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R54400
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